Long-Acting Amylin Analogue • Coming Soon
A New Pathway for Weight Management
Cagrilintide is a long-acting amylin analogue that works differently from GLP-1 medications. By mimicking the satiety hormone amylin, it promotes fullness through distinct brain pathways. In the Phase 3 REDEFINE 1 trial, CagriSema (cagrilintide plus semaglutide) showed -20.4% mean body-weight change vs -3.0% with placebo at 68 weeks. Join our waitlist to be notified when available.
20.4%
CagriSema Avg Weight Loss*
68
Week Phase 3 Trial
1x
Weekly Injection
Not Yet
FDA Approved
Coming Soon
A novel amylin analogue offering a different approach to weight management. This medication works through satiety pathways distinct from GLP-1 therapies.
5mg per vial
Potential For
Patients seeking an alternative approach to appetite control, or those who may not tolerate GLP-1 medications well due to gastrointestinal side effects.
The Science
Cagrilintide is a long-acting analogue of amylin, a hormone naturally released by the pancreas alongside insulin after meals. Amylin promotes satiety by signaling fullness to the brain through pathways distinct from GLP-1—offering a complementary approach to appetite control.
Unlike GLP-1 receptor agonists (like semaglutide), cagrilintide targets amylin and calcitonin receptors in the brainstem. This different mechanism may explain why combining cagrilintide with GLP-1 therapy (CagriSema) produces greater weight loss than either alone.
In the Phase 3 REDEFINE 1 trial, which also included a cagrilintide-only group (see trial data), the combination with semaglutide was the primary focus over 68 weeks; cagrilintide alone is being studied for a lower incidence of nausea and vomiting, making it a potential option for patients who don't tolerate GLP-1 medications well.
Join the Waitlist
How It Works
Cagrilintide works through a distinct mechanism from GLP-1 medications, targeting satiety through different brain regions.
Mimics natural amylin released by the pancreas, signaling satiety to the area postrema and other brainstem regions involved in appetite control.
Slows the rate at which food leaves the stomach, prolonging feelings of fullness after meals and reducing overall food intake.
Works through different neural pathways than GLP-1, which is why combining cagrilintide with semaglutide (CagriSema) enhances weight loss beyond either alone.
Clinical Trial Results
Cagrilintide offers comparable weight loss to GLP-1 therapies with a potentially better tolerability profile for some patients.
*Phase 3 REDEFINE trial results. Not yet FDA approved.
Potential Benefits
Works through amylin receptors rather than GLP-1, offering an alternative pathway for patients who may not respond optimally to GLP-1 medications alone.
Phase 3 data showed lower rates of nausea and vomiting compared to GLP-1 therapies—potentially better tolerated for some patients.
Weight loss as monotherapy is being evaluated in Phase 3 trials; see trial data for published results.
When combined with semaglutide (CagriSema), achieved 20.4% mean weight loss at 68 weeks in REDEFINE 1—demonstrating synergy between amylin and GLP-1 pathways.
Amylin helps regulate post-meal glucose levels, and glucose effects are being studied in the trial program.
Once-weekly subcutaneous injection at the therapeutic dose of 2.4mg—simple to incorporate into any routine.
What to Do Now
Cagrilintide isn't available yet, but you don't have to wait to start your weight loss journey. Here's how we can help today.
Sign up to be notified when cagrilintide receives FDA approval and becomes available at BHRC.
Meet with our providers to discuss FDA-approved options like semaglutide or tirzepatide that are available now.
Begin your weight loss journey with FDA-approved therapies while monitoring cagrilintide's progress through approval.
When cagrilintide becomes available, discuss with your physician whether it's right for your goals and tolerance profile.
Clinical Trial Status
Cagrilintide has completed Phase 3 clinical trials (the REDEFINE program) by Novo Nordisk. While results are promising, it has not yet received FDA approval for commercial use.
REDEFINE
Phase 3 clinical program evaluating cagrilintide alone and with semaglutide
3,400+
Participants in the REDEFINE 1 trial across multiple countries
At a glance
Your plan
If you come in asking about cagrilintide, the BHRC clinical team starts with what can actually be prescribed today. We review your weight history, previous medications and how you tolerated them, especially any GLP-1 side effects that are behind your interest in an amylin drug.
Metabolic labs, blood pressure and body composition give a starting point that stays useful whatever medication you end up on. We also note any history that would rule out a GLP-1, such as a family history of medullary thyroid cancer, so the plan accounts for it from the start. If cagrilintide is ever approved and prescribed, those same baselines make the comparison meaningful.
For most patients that means an FDA-approved medication such as semaglutide or tirzepatide where appropriate, with a slower titration if nausea has been a problem before, plus nutrition and resistance-training guidance to protect lean mass.
Follow-up visits track weight, side effects, protein intake and labs. Tolerability problems are solved by adjusting the plan, such as holding a dose step, changing injection day or reworking meals, not by switching to an unapproved product. Weight plateaus are reviewed against body-composition data, because the goal is fat loss with lean mass preserved, not the scale number alone.
If FDA approves a cagrilintide product, waitlisted patients are contacted, and the clinical team reviews the approved label, who it is for and whether switching or adding it would make sense for you. Until then, it is not part of any BHRC protocol.
Timeline
Cagrilintide is investigational. You cannot be prescribed it at BHRC, and any vial sold online as cagrilintide is an unapproved, unverified product.
Novo Nordisk has run phase 3 programmes (REDEFINE in obesity, REIMAGINE in type 2 diabetes) and a cardiovascular outcomes trial is under way. Results are published as they mature.
FDA's decision would rest on the full trial data and would set the approved indication, the population and the label warnings. Timing is decided by FDA, not by clinics.
The approved product would become a prescription option like any other, and the BHRC team would review it against your history and current plan.
Most patients who would be candidates are already eligible for an approved weight-management medication today, so waiting is usually not necessary and can cost months of progress.
Compare
| Option | Pathway | FDA status (Oct 2026) | What it means for you |
|---|---|---|---|
| Cagrilintide (alone) | Amylin and calcitonin receptors | Investigational, not approved | Trial participation only |
| CagriSema (cagrilintide + semaglutide) | Amylin plus GLP-1 | Investigational, not approved | Phase 3 data published; no prescription route |
| Semaglutide | GLP-1 | Approved (Wegovy for weight management) | Available now after consultation; see our semaglutide page |
| Tirzepatide | GIP plus GLP-1 | Approved (Zepbound for weight management) | Available now after consultation; see our tirzepatide page |
Is it right for you?
Monitoring
Because cagrilintide is not prescribed at BHRC, there is no cagrilintide monitoring protocol here. What we monitor is the approved plan you are actually on: weight trend, waist measurement, appetite, nausea, constipation, hydration, protein intake and the labs that matter for your history. Gastrointestinal side effects were common in the CagriSema phase 3 trial as well, so the idea that an amylin drug would be side-effect-free is not supported by the data published so far.
We also monitor the regulatory picture. Drugs@FDA is checked for any approved product containing cagrilintide, and if one appears, this page and the waitlist are updated. Until then, the BHRC clinical team treats any 'research peptide' labelled cagrilintide as an unapproved product of unknown identity, purity and sterility, and will not supervise its use.
What is cagrilintide being studied for? The published programme focuses on weight management in adults with obesity or overweight, glucose control in type 2 diabetes when combined with semaglutide, and, in a dedicated outcomes trial, cardiovascular events. Mechanistic work in animals suggests its weight effect runs through brain amylin receptors. None of that has been converted into an approved indication yet, which is why the BHRC team describes it as a drug to watch rather than a drug to take.
Why are people interested in an amylin drug at all? Mostly tolerability and plateaus. Some patients stop a GLP-1 because of nausea, and others reach a plateau and wonder whether a second pathway would help. Both are real clinical problems, and both have approved-medication answers today: slower titration, dose holds, dietary changes that reduce nausea, a switch between approved agents, or a review of whether the plateau is the right weight to maintain. The team works through those before anyone needs to wait for a new molecule.
Would you have to stop your current medication to switch if cagrilintide were approved? That question only becomes real once an approved label exists. At that point the clinical team would review the label, your response to your current medication and your labs before suggesting any change. There is no reason to stop an effective approved medication while waiting.
Considering a clinical trial? A registered trial is the one legitimate way to receive cagrilintide before approval, and it comes with its own monitoring. Before enrolling, it helps to check the trial phase, whether there is a placebo group (you may not receive the active drug), the visit schedule and travel involved, what happens to your care when the trial ends, and whether you would need to stop any current medication to qualify. Bring the listing to a BHRC consultation and the clinical team will go through the eligibility criteria with you; we do not run these trials and receive nothing for referrals.
If you are taking an unapproved product already, tell us at consultation. You will not be judged for it; the team needs to know so that side effects can be interpreted correctly and so that any approved medication is started safely.
Dosing, reconstitution and cycling detail is covered in our Cagrilintide dosage guide and related dosage guide. Your own plan is set by your provider at the consultation.
Regulatory status
Cagrilintide is an investigational drug. It is not FDA-approved, alone or in combination with semaglutide, and Drugs@FDA lists no approved product containing it. It is available only to participants in registered clinical trials, and BHRC does not prescribe, compound or dispense it. Any prescription weight-management medication at BHRC is an FDA-approved product, prescribed only after a provider consultation and ongoing follow-up. Prepared by the BHRC team from FDA and PubMed sources.
Before you book
No. As of October 2026, Drugs@FDA lists no approved product containing cagrilintide, alone or combined with semaglutide. It is an investigational drug available only to people enrolled in registered clinical trials.
No. It is an amylin analogue. Amylin is a separate satiety hormone released with insulin, and cagrilintide acts on amylin and calcitonin receptors rather than the GLP-1 receptor. It is often discussed with GLP-1 drugs because the furthest-advanced product, CagriSema, pairs it with semaglutide.
Not as a prescription. No US clinic can legitimately prescribe an approved cagrilintide product because none exists yet. The only legitimate route is a clinical trial; ClinicalTrials.gov lists active studies, and our team can help you read the eligibility criteria.
Those vials are not approved, not made under drug-manufacturing oversight for human use, and not tested for you. The label may not match the contents. The BHRC clinical team does not prescribe, dispense or supervise them, and we recommend against using them.
In REDEFINE 1, published in the New England Journal of Medicine, 3,417 adults without diabetes were randomised. At 68 weeks the mean body-weight change was -20.4% with cagrilintide-semaglutide compared with -3.0% with placebo, and gastrointestinal side effects were reported by 79.6% versus 39.9%. These are trial results in a selected population, not a prediction for any individual.
Dosing is not set at BHRC because it is not prescribed here. Trial titration schedules and published data are summarised in our cagrilintide and CagriSema guide, which is background reading rather than instructions.
Start with a consultation for an approved option. Semaglutide and tirzepatide are FDA-approved for chronic weight management in eligible adults, and the BHRC team adjusts titration speed, nutrition and follow-up around how you tolerate them. Our 2026 weight-loss peptides guide explains which products are approved and which are not.
We cannot say yet. Cost will depend on the approved product, insurance coverage, the consultation and the follow-up schedule. For approved options available now, your BHRC centre provides an itemised quote at consultation; we do not list prices on this page.
Not yet. Approved drugs receive a brand name at approval; until then, cagrilintide is referred to by its generic name, and CagriSema is a development name for the combination with semaglutide. A product sold under any brand-like name today is not an approved cagrilintide product.
Use the waitlist form on this page or book a consultation at any BHRC centre. Joining the waitlist does not commit you to anything, and you can start an approved plan at the same time.
Selected research
The literature below is peer-reviewed background on Cagrilintide and the mechanisms discussed on this page, so you can read the primary sources yourself. It is not evidence of any particular outcome at BHRC, and some of it is preclinical work in animals or cells. Your provider will discuss what the evidence does and does not support for your situation.
Related peptide therapies
Questions
No, cagrilintide is not yet FDA approved. It has completed Phase 3 clinical trials (the REDEFINE program) with positive results, and Novo Nordisk is expected to seek FDA approval. Any availability depends on a future FDA decision.
Cagrilintide is an amylin analogue that targets amylin and calcitonin receptors, while semaglutide is a GLP-1 receptor agonist. They work through different brain pathways to promote satiety. This is why combining them (CagriSema) produces greater weight loss than either alone—the mechanisms are complementary rather than redundant.
Amylin is a hormone naturally produced by the pancreas and released alongside insulin after meals. It signals fullness to the brain, slows gastric emptying, and helps regulate post-meal blood sugar. Cagrilintide is a long-acting synthetic version that mimics these effects with once-weekly dosing.
Phase 3 data suggests cagrilintide may have lower rates of nausea and vomiting compared to GLP-1 therapies like semaglutide. However, gastrointestinal side effects (nausea, constipation, diarrhea) still occur, typically mild to moderate in severity. Individual tolerance varies, and our physicians can help determine what's right for you.
CagriSema is a combination of cagrilintide (2.4mg) and semaglutide (2.4mg) in a single weekly injection. In the Phase 3 REDEFINE 1 trial, CagriSema achieved a mean body-weight change of -20.4% vs -3.0% with placebo at 68 weeks—significantly more than either component alone. It's also in Phase 3 trials and not yet FDA approved.
Cagrilintide is not yet available outside of clinical trials. Be cautious of any source claiming to sell cagrilintide—these products are unregulated and potentially dangerous. If you're interested in weight loss treatment now, we offer FDA-approved options like semaglutide and tirzepatide.
Once available, cagrilintide may be particularly suitable for patients who experience significant GI side effects with GLP-1 medications, those seeking an alternative mechanism for appetite control, or as part of combination therapy for enhanced results. Our physicians can help determine the best approach for your individual needs.
Stay Updated
Be the first to know when cagrilintide becomes available. In the meantime, our team can discuss FDA-approved options like semaglutide and tirzepatide.
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*Cagrilintide is an investigational medication that has completed Phase 3 clinical trials but is NOT yet FDA approved for commercial sale. The weight loss figure cited (CagriSema -20.4% vs -3.0% placebo at 68 weeks) is from the REDEFINE 1 trial. Cagrilintide is only available through clinical trial participation until FDA approval. Any source claiming to sell cagrilintide outside of clinical trials is unregulated and potentially dangerous. BHRC does not currently offer cagrilintide. This page is for informational purposes only. Consult with our medical team about FDA-approved weight loss options available today.
